Glenmark Pharmaceuticals Receives ANDA Approval for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC)

Glenmark Pharmaceuticals Ltd. has announced that it has received final approval by the U.S. FDA for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), which is bioequivalent to Nexium® 24 HR Delayed-Release Capsules, 20 mg (OTC), of Haleon U.S. Holdings LLC. The product will be distributed in the U.S. by Glenmark Therapeutics Inc., USA. The Nexium® 24 HR Delayed-Release Capsules, 20 mg (OTC) market achieved annual sales of approximately $259.2 million. Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace and 50 ANDA’s pending approval with the U.S. FDA.